Breaking Data on the Efficacy and Cost-Effectiveness of an Exclusive Human Milk Diet for Premature Infants To Be Presented at the American Academy of Pediatrics 2022 National Conference

DUARTE, Calif., Oct. 7, 2022 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced today that two breaking studies on an Exclusive Human Milk Diet (EHMD) will be presented as Poster Presentations at the 2022 American Academy of Pediatrics (AAP) National Conference to be held October 7-11 in Anaheim, California. 

One study based on real-world data from seven U.S. hospitals demonstrates the efficacy and cost-effectiveness of an EHMD for premature infants.

• "Implementing an Exclusive Human Milk Diet for Preterm Infants: Real-World Experience in Diverse NICUs" – An EHMD is associated with improved outcomes for very low birth weight (VLBW) preterm infants in the neonatal intensive care unit (NICU).^1-7 On Sunday, Oct. 9 from noon to 1 p.m. Pacific Time, Jenny Fox, MD, MPH, of Children's Hospital of Richmond at Virginia Commonwealth University in Richmond, Virginia, will interact with attendees and answer questions about her research, which is intended to rectify a current lack of real-world clinical data on the efficacy and cost-effectiveness of an EHMD. Poster data were drawn from a virtual expert roundtable in 2020 where NICU leaders from seven diverse U.S. hospitals shared their policies and insights regarding an EHMD with the goal of providing a model to other institutions wishing to establish an EHMD in their NICUs.

"These collaborative data fill gaps in evidence-based medicine for NICU leaders and provide support for implementing an EHMD for very preterm infants," Dr. Fox said. "Our study provides additional evidence that hospitals, regardless of size and type, can incorporate an EHMD to improve complications while reducing overall costs."

Another study provides real-world data on the benefits of an EHMD in premature infants born weighing less than 750 g.

• "Associations of an Exclusive Human Milk Diet With Morbidity and Mortality in ELBW Infants Born Weighing ≤750 Grams: An Individual Participant Data Meta-Analysis" – An EHMD has shown promising results in clinical trials to reduce health complications of prematurity in infants weighing less than 1,250 g compared to traditionally used cow milk-based fortifiers or preterm infant formulas.^2-5,7-9 A team of authors led by Sarah M. Reyes, PhD, Prolacta's scientific liaison for human milk and clinical research, conducted a meta-analysis of published studies to examine whether this reduction in complications extended to the smallest extremely low birth weight (ELBW) infants, those born weighing less than 750 g.

"An EHMD performed well in ELBW infants born weighing less than 750 g compared to cow milk-based nutritional products," Dr. Reyes said. "Our study provides more evidence that a health care provider can feed the EHMD to even the most vulnerable infant safely, effectively, and without compromise." Dr. Reyes will be available to discuss the findings, which were based on individual patient data, on Saturday, Oct. 8 from 5:15 p.m. to 6 p.m. Pacific Time.

"It's an honor to be chosen to present our findings at the AAP National Conference. The evidence continues to mount that an EHMD provides tangible short-term and long-term benefits for our critically ill, premature patients. Both meta-analyses and real-world data are an important part of that overall picture," said Melinda J. Elliott, MD, chief medical officer of Prolacta, a practicing neonatologist, and a co-author of the individual participant data meta-analysis.

The posters will be on display on Saturday, Oct. 8 and Sunday Oct. 9, from 10 a.m. to 6 p.m. Pacific Time in Hall A of the Anaheim Convention Center, Anaheim Marriott, Marquis Ballroom Center.

The major difference between cow milk-based and human milk-based products is the composition — notably, the bioactive components that are unique to human milk. These include immunoglobulins, lactoferrin, milk fat globule membrane, and the wide spectrum of prebiotics known as human milk oligosaccharides (HMOs), which are not easily manufactured and thus are greatly decreased or missing from cow milk-based nutritional products.¹⁰ Bioactivity is thought to support infants' immunity, development, growth, and long-term health.¹¹

Prolacta's 100% human milk-based nutritional products have the highest bioactivity in the human milk industry.¹² Prolacta's nutritional products are vat pasteurized using profiles defined by the U.S. Food and Drug Administration (FDA) to ensure pathogen inactivation and the highest level of safety while retaining as much of the natural bioactivity of the milk as possible.¹² Prolacta's vat pasteurized products retain higher bioactivity than products processed using other methods, including retort sterilization and ultra-high-temperature (UHT) processing.^13,14

Prolacta Bioscience® Inc. is a privately held, global life sciences company dedicated to Advancing the Science of Human Milk® to improve the health of critically ill, premature infants. Prolacta's 100% human milk-based nutritional products have been evaluated in more than 20 clinical studies published in peer-reviewed journals. More than 80,000 premature infants have benefited from Prolacta's nutritional products worldwide to date.¹⁵ Established in 1999, Prolacta is the world's leading provider of human milk-based nutritional products for hospital use and is also exploring the therapeutic potential of human milk across a wide spectrum of diseases. Prolacta maintains the industry's strictest quality and safety standards for screening, testing, and processing donor human milk. Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta uses vat pasteurization and a patented, FDA-reviewed manufacturing process to ensure pathogen inactivation while protecting the nutritional composition and bioactivity of its human milk-based products. Prolacta is a global company with headquarters in Duarte, California, and can be found online at www.prolacta.com, on Twitter, Instagram, Facebook, and LinkedIn.

Media Contact:

Loren Kosmont

Lkosmont@prolacta.com

310-721-9444

References

1.  Swanson, J., Becker, A., Fox, J., Horgan, M., Moores, R., Pardalos, J., Pinheiro, J., Stewart, D. and Robinson, T., 2022. Implementing an Exclusive Human Milk Diet for Preterm Infants: Real-world Experience in Diverse NICUs. In: American Academy of Pediatrics National Conference.

2.  Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168

3.  Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet [published correction appears in Breastfeed Med. 2017;12(10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134

4.  Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med. 2014;9(6):281-285. doi:10.1089/bfm.2014.0024

5.  Cristofalo EA, Schanler RJ, Blanco CL, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013 Dec;163(6):1592-1595.e1. doi: 10.1016/j.jpeds.2013.07.011. Epub 2013 Aug 20.

6.  Agostoni C, Buonocore G, Carnielli VP, et al. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0

7.  Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-567.e1. doi:10.1016/j.jpeds.2009.10.040

8.  Reyes S. Associations of an Exclusive Human Milk Diet With Morbidity and Mortality in ELBW Infants Born Weighing ≤750 Grams: An Individual Participant Data Meta-Analysis. In: American Academy Of Pediatrics National Conference; 2022.

9.  Delaney Manthe E, Perks PH, Swanson JR. Team-based implementation of an exclusive human milk diet. Adv Neonatal Care. 2019;19(6):460-467. doi:10.1097/ANC.0000000000000676

10.  Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013;60(1):49-74. doi:10.1016/j.pcl.2012.10.002

11.  Gila-Diaz A, Arribas SM, Algara A, et al. A review of bioactive factors in human breastmilk: a focus on prematurity. Nutrients. 2019;11(6):1307. doi:10.3390/nu11061307

12.  Internal data.

13.  Lima HK, Wagner-Gillespie M, Perrin MT, Fogleman AD. Bacteria and bioactivity in Holder pasteurized and shelf-stable human milk products. Curr Dev Nutr. 2017;1(8):e001438. doi:10.3945/cdn.117.001438

14.  Meredith-Dennis L, Xu G, Goonatilleke E, Lebrilla CB, Underwood MA, Smilowitz JT. Composition and variation of macronutrients, immune proteins, and human milk oligosaccharides in human milk from nonprofit and commercial milk banks. J Hum Lact. 2018;34(1):120-129. doi:10.1177/0890334417710635

15.  Estimated number of premature infants fed Prolacta's products from January 2007 to December 2021; data on file.

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SOURCE Prolacta Bioscience